Emergency ContraceptionPhase 3LIBRellaNCT03208985

A Study of Use of Ella®, an Emergency Contraceptive, Under Simulated OTC Conditions

A Phase 3 study testing Use Phase (Ulipristal Acetate, 30 mg) in people with Emergency Contraception, run by HRA Pharma at 34 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is designed to assess whether consumers select and use ella® (ulipristal acetate 30mg), an emergency contraceptive, in a manner consistent with the OTC package directions in an OTC-like setting. Read more about this study

Who is it for?: Any age, women onlyHealthy volunteers can take part
Conditions the study is for: Emergency Contraception
What is being tested?: Use Phase (Ulipristal Acetate, 30 mg)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,270 participants
Where: 34 sitesUnited States
Study dates: 23 May 2017to 14 Jun 2018
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
Women only
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Women who are self-pay or who are willing to be self-pay for the purposes of the study and who present for emergency contraception only for their own use

Who cannot join

Cannot read, speak and understand English
Cannot see well enough to read information on the label

Trial locations and contacts

34 sites in 1 country.

City, postcode or hospital

34 sites in 1 country

United States34 sites

HRA Pharma Investigational Site
Albuquerque, New Mexico, 87104
HRA Pharma Investigational Site
Albuquerque, New Mexico, 87109
HRA Pharma Investigational Site
Andover, Minnesota, 55304
HRA Pharma Investigational Site
Belleville, Illinois, 62226
HRA Pharma Investigational Site
Boulder, Colorado, 80302
HRA Pharma Investigational Site
Bremerton, Washington, 98310
HRA Pharma Investigational Site
City of Saint Peters, Missouri, 63376
HRA Pharma Investigational Site
Denver, Colorado, 80003
HRA Pharma Investigational Site
Denver, Colorado, 80207
HRA Pharma Investigational Site
Durham, North Carolina, 27704
HRA Pharma Investigational Site
Fort Myers, Florida, 33919
HRA Pharma Investigational Site
Hackensack, New Jersey, 07601
HRA Pharma Investigational Site
Kansas City, Missouri, 64111
HRA Pharma Investigational Site
Las Vegas, Nevada, 89102
HRA Pharma Investigational Site
Manchester, Missouri, 63088
HRA Pharma Investigational Site
Miami, Florida, 33133
HRA Pharma Investigational Site
Morristown, New Jersey, 07960
HRA Pharma Investigational Site
New Brunswick, New Jersey, 08901
HRA Pharma Investigational Site
New York, New York, 10012
HRA Pharma Investigational Site
Orlando, Florida, 32817
HRA Pharma Investigational Site
Pembroke Pines, Florida, 33026
HRA Pharma Investigational Site
Portland, Oregon, 97212
HRA Pharma Investigational Site
Puyallup, Washington, 98373
HRA Pharma Investigational Site
Raleigh, North Carolina, 27603
HRA Pharma Investigational Site
Rancho Cucamonga, California, 91730
HRA Pharma Investigational Site
Saint Louis Park, Minnesota, 55426
HRA Pharma Investigational Site
Seattle, Washington, 98122
HRA Pharma Investigational Site
Seattle, Washington, 98133
HRA Pharma Investigational Site
St Louis, Missouri, 63108
HRA Pharma Investigational Site
St Louis, Missouri, 63118
HRA Pharma Investigational Site
St. Petersburg, Florida, 33701
HRA Pharma Investigational Site
Tacoma, Washington, 98405
HRA Pharma Investigational Site
Tampa, Florida, 33617
HRA Pharma Investigational Site
Trenton, New Jersey, 08608

Other trials in United States

About this study

Official title: A Multi-Center, Open-Label Trial Investigating Behavior Related to Ella® Use in a Simulated OTC Environment (LIBRella)

Read the detailed description

All potential subject coming to a site looking to purchase EC will be offered to participate in the study. Subjects who meet the initial screening inclusion criteria for the study will review package information and make a self-selection and purchase decision. Subjects who meet all remaining inclusion criteria will purchase ella®, and use based on their understanding of the package information.

Follow-up data regarding product use and adverse events will be obtained during telephone interviews at approximately Week-2 and Week-6 after the date the subject was dispensed study product.

Conditions: Emergency Contraception
Being tested: Use Phase (Ulipristal Acetate, 30 mg)
Keywords: Emergency contraception

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Use Phase (Ulipristal Acetate, 30 mg)Drug
All subjects enrolled in the use phase of this open-label study will be given the opportunity to purchase and take 30 mg of ulipristal acetate.
Subjects are to use the investigational product based on their understanding of the directions on the outer packaging including Drug Facts Label and inside the product packaging (in the Consumer Information Leaflet).

Study groups in NCT03208985
Study group	Role	What they receive
Use Phase (Ulipristal Acetate, 30 mg)	Experimental	One tablet of 30 mg of ulipristal acetate for emergency contraception Receives: Drug: Use Phase (Ulipristal Acetate, 30 mg)

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of Dosing Instances Among User Population Taken Within 120 Hours (5 Days) of Most Recent Episode of Unprotected Sex.
The first primary endpoint is the proportion in which the denominator includes all dosing instances of the IP and the numerator includes all dosing instances of the IP which were taken within 120 hours (5 days) of the subject's most recent episode of unprotected sex.
Measured: Up to 6 Weeks
Proportion of Dosing Instances Among User Population in Which no More Than One Tablet Was Taken.
The second primary endpoint is the proportion in which the denominator is all discrete dosing instances of the IP and the numerator includes all dosing instances where no more than one tablet was taken.
Measured: Up to 6 Weeks
Proportion of Female Selectors Who Are Not Pregnant at the Time of Selection Decision.
The third primary endpoint is the proportion in which the denominator includes all females who selected to use the product (regardless of whether they purchased/used) and the numerator includes all female selectors who were not pregnant at the time of the selection decision.
Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 May 201714 Jun 2018

First posted6 Jul 2017
Study start23 May 2017
Primary completion14 Jun 2018
Study completion14 Jun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Emergency ContraceptionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 1,270 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03208985
Sponsor's protocol ID: 151032-001
Acronym: LIBRella
Status last verified: Nov 2022
First submitted: 26 Jun 2017
Last updated: 2 Dec 2022
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Disparities in Emergency Contraceptive Metabolism Dictate Efficacy
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All Emergency Contraception trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Center, Open-Label Trial Investigating Behavior Related to Ella® Use in a Simulated OTC Environment (LIBRella)
ClinicalTrials.gov ID: NCT03208985
Acronym / sponsor ID: LIBRella / 151032-001
Conditions: Emergency Contraception
Keywords: Emergency contraception
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,270 participants (actual)
Lead sponsor: HRA PharmaIndustry (pharma, biotech, devices)
Study start: 23 May 2017 (actual)
Primary completion: 14 Jun 2018 (actual)
Study completion: 14 Jun 2018 (actual)
First posted: 6 Jul 2017 (actual)
Results: Posted 2 Dec 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Follow-up data regarding product use and adverse events will be obtained during telephone interviews at approximately Week-2 and Week-6 after the date the subject was dispensed study product.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Use Phase (Ulipristal Acetate, 30 mg)	Experimental	Drug: Use Phase (Ulipristal Acetate, 30 mg)One tablet of 30 mg of ulipristal acetate for emergency contraception

Who may qualify

Sex: Female only
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

Women who are self-pay or who are willing to be self-pay for the purposes of the study and who present for emergency contraception only for their own use

Key exclusion criteria (2 listed)

Cannot read, speak and understand English
Cannot see well enough to read information on the label

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Use Phase (Ulipristal Acetate, 30 mg)All subjects enrolled in the use phase of this open-label study will be given the opportunity to purchase and take 30 mg of ulipristal acetate. Subjects are to use the investigational product based on their understanding of the directions on the outer packaging including Drug Facts Label and inside the product packaging (in the Consumer Information Leaflet).	Drug	Use Phase (Ulipristal Acetate, 30 mg)

Primary outcome

Proportion of Dosing Instances Among User Population Taken Within 120 Hours (5 Days) of Most Recent Episode of Unprotected Sex.
Time frame: Up to 6 Weeks
The first primary endpoint is the proportion in which the denominator includes all dosing instances of the IP and the numerator includes all dosing instances of the IP which were taken within 120 hours (5 days) of the subject's most recent episode of unprotected sex.
Proportion of Dosing Instances Among User Population in Which no More Than One Tablet Was Taken.
Time frame: Up to 6 Weeks
The second primary endpoint is the proportion in which the denominator is all discrete dosing instances of the IP and the numerator includes all dosing instances where no more than one tablet was taken.
Proportion of Female Selectors Who Are Not Pregnant at the Time of Selection Decision.
Time frame: Day 1
The third primary endpoint is the proportion in which the denominator includes all females who selected to use the product (regardless of whether they purchased/used) and the numerator includes all female selectors who were not pregnant at the time of the selection decision.

Results and safety

Results posted to the registry on 2 Dec 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Self-Selection Population	1,270	868

Primary outcome: Proportion of Dosing Instances Among User Population Taken Within 120 Hours (5 Days) of Most Recent Episode of Unprotected Sex.

Time frame: Up to 6 Weeks. Number. Unit: Dosing instances 120 hrs of unprotec.sex

Measure	Use Phase (Ulipristal Acetate, 30 mg) n = 681
Value	704

Population analysed: User Population: subjects who have taken at least one dose of study medication during the study.

Primary outcome: Proportion of Dosing Instances Among User Population in Which no More Than One Tablet Was Taken.

Time frame: Up to 6 Weeks. Number. Unit: Dosing no more than 1 tablet was taken

Measure	Use Phase (Ulipristal Acetate, 30 mg) n = 681
Value	712

Primary outcome: Proportion of Female Selectors Who Are Not Pregnant at the Time of Selection Decision.

Time frame: Day 1. Count of participants. Unit: Participants

Measure	Self-Selection Population n = 819
Value	814

Population analysed: Subjects who accepted the invitation to participate and met study inclusion criteria, participated in a face-to-face interview at the study site and made a self-selection and purchase decision, have performed an enrollment pregnancy test and either have answered 'No' to the question 'Are you currently pregnant?'

Adverse events

Time frame: up to 6 weeks. Other adverse events reported at 0.1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Safety Population	15 of 783 (1.9%)	132 of 783 (16.9%)	0 of 783

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Disparities in Emergency Contraceptive Metabolism Dictate Efficacy
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Russel Bradford, MD, MSPH principal investigator

Pegus Research, Inc.

34 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Use Phase (Ulipristal Acetate, 30 mg) in people with Emergency Contraception, run by HRA Pharma at 34 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Dosing Instances Among User Population Taken Within 120 Hours (5 Days) of Most Recent Episode of Unprotected Sex. (time frame: Up to 6 Weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03208985.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2022.